This content is current only at the time of printing. This document was printed on 21 February 2017. A current copy is located at http://apvma.gov.au/node/335
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Trade-related aspects of intellectual property rights
Australia has obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set out Annex 1C to the Marrakesh Agreement establishing the World Trade Organization. Part 7B of the Admin Act gives effect to these obligations.
Part 7B of the Admin Act limits the use the APVMA can make of (and affords protection to) information given to the APVMA in connection with a previous application made to the APVMA for approval of an active constituent for a proposed or existing chemical product where:
- the previous application was made to the APVMA between 1 April 1999 and 31 December 2004 (inclusive)
- the information given to the APVMA in connection with the previous application has not been made publicly available in Australia, and
- at the time immediately before the previous application was made, no application had been made to the APVMA for approval of the active constituent to which that application related.
This information is often referred to as TRIPS protected data or information.
The APVMA cannot grant a new application for approval of an active constituent for a proposed or existing chemical product that seeks to rely on the APVMA using TRIPS protected information:
- the person who made the application has given information to the APVMA that makes it unnecessary for the APVMA to use the TRIPS protected information in connection with the new application
- the person who made the application has given to the APVMA evidence that satisfies the APVMA that the person who made the previous application (with TRIPS protected information) has consented to the APVMA using the TRIPS protected information in connection with the new application
- at least five years has elapsed since the previous application (with TRIPS protected information) was determined by the APVMA or withdrawn, as the case may be.
When making an application to us for active constituent approval that is reliant on a reference active constituent you are required to check if the information associated with the reference active constituent is TRIPS protected information. If it is, and the five-year protection period has not elapsed, prior to making the application you are required to arrange consent from the approval holder of the reference active constituent for the use of the TRIPS protected information. The list of agricultural and veterinary active constituents that have TRIPS protection is available.